Kornimate/medical-research-clean huggingface dataset:
platelet rich plasma (prp) and high intensity focused ultrasound (hifu) in management of stress urinary incontinence (sui): pilot study

Conditions: Urinary Incontinence

Summary: previous studies results show (prp) is safe and effective in treating sui, other studies show the result of energy base devices (co2 laser, hifu) are effective in treating of sui . this study add the effect both hifu and prp together in treating sui.

what is stress urinary incontinence (sui)? stress urinary incontinence (sui) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly. with mild sui, pressure may be from sudden forceful activities, like exercise, sneezing, laughing or coughing. if your sui is more severe, you may also leak with less forceful activities like standing up, walking or bending over. urinary "accidents" like this can range from a few drops of urine to enough to soak through the clothes sui is a very common bladder problem for women. key sui statics about half of women age 65 and above find that they sometimes leak urine. how can sui affect life? many people find that sui gets in the way of daily and social activities. it can affect family and sexual relationships. some people even begin to feel isolated and hopeless because of it the pelvic floor supports the bladder and urethra. if this area gets stretched, weakened or damaged, then sui can happen. pregnancy and childbirth can cause this. prp is extremely rich in growth factors and cytokines which regulate tissue reconstruction, prp is an easily procedure and relatively inexpensive biological material, it is produce directly from patient blood and inject prp under urethra to restore bulbourethral ligment . hifu is an energy-based medical technology with many clinical applications, a device is a non-invasive procedure that provides collagen remodeling and synthesis that may repair and restore pelvic floor and pubourethral ligment, it is non-invasive therapeutic technique, that uses non-ionized ultrasonic waves that provides collagen that tight the endopelvic fascia and adjacent tissues .

Eligibility criteria:
inclusion criteria: * women complain of sui is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change (american urological association 2017). * positive cough test when filled urinary bladder. * women chose non-invasive management rather than surgical management. • • among the 20 patients enrolled, the average age was 30-60 years old. * urodynamic study proven the diagnosis. exclusion criteria: * patient of previous operation or radiation * uncontrolled diabetes neuromuscular disorder * uncontrolled psychiatric diseases * pregnancy * lactation * virgin * sepsis * active carcinoma * cystocele. * antiplatelet drug intake less than 7 days before and after procedure. - bleeding disorder. * patients cannot deal with questionnaires.
treatment of concomitant mitral regurgitation by mitral valve clipping in patients with successful transcatheter aortic valve implantation.

Conditions: Aortic Stenosis; Mitral Regurgitation

Summary: to evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (tavi), who have concomitant, moderate to severe mitral regurgitation (mr) benefit from an additional treatment of this valve disease as well.


Eligibility criteria:
inclusion criteria * planned transfemoral tavi using an edwards sapien 3 transcatheter heart valve (or subsequent models) * moderate to severe mitral regurgitation * symptom status nyha ii-iii * treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion * age ≥ 18 and \< 90 years * written informed consent exclusion criteria * mr mechanism/anatomy precluding mitraclip therapy * groin blood vessels are not eligible for tavi procedure * massive or torrential tricuspid regurgitation * patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen. * life expectancy \< 1 year due to non-cardiac conditions * lvef ≤ 25% * hypotension (systolic pressure \< 90 mmhg) or requirement of inotropic support or mechanical hemodynamic support * cardiomyopathy other than dilated cardiomyopathy * fixed pulmonary artery systolic pressure \> 70 mm hg * any prior mitral valve surgery or transcatheter mitral valve procedure * stroke or transient ischemic event within 6 months prior to randomization * severe symptomatic carotid stenosis * implant or revision of any rhythm management device (crt or crt-d) or implantable cardioverter defibrillator within 90 days prior to randomization * untreated clinically significant coronary artery disease requiring revascularization * any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization. * need for any other cardiovascular surgery (other than mv or av disease) * echocardiographic evidence of intracardiac mass, thrombus, or vegetation * active endocarditis or active infections requiring current antibiotic treatment * any condition making it unlikely that the patient will be able to complete all protocol procedures * patient unable to provide written informed consent prior to study enrolment * pregnant or nursing women * women of child bearing potential * current participation in any other interventional clinical trial * patients under legal supervision or guardianship patients placed in an institution by official or court order

Keywords: aortic stenosis aortic disease transcatheter aortic valve implantation mitral regurgitation mitral valve regurgitation mitral disease mitral valve clipping mitraclip heart valve diseases
secondary databased post-marketing surveillance study of bnt162b2

Conditions: COVID-19; SARS-CoV-2

Summary: this study is to assess the post-marketing safety of bnt162b2 products using nationwide population-based database in republic of korea.

this study is a retrospective, non-interventional, observational study using korean disease control and prevention agency-covid-19-national health insurance service (k-cov-n) database that includes covid-19 vaccination/infection and claims data in korean population. for the primary objective, cohort and self-controlled design will be used for measure of occurrence and measure of association, respectively. for the secondary objective, cohort design will be used for measure of occurrence. primary objective: * to describe the frequency and estimate the incidence ratio of adverse events of special interest (aesis) following exposure to comirnaty injection among individuals aged 6 months or older in the republic of korea * to evaluate the relative risk of aesis following exposure to comirnaty injection among individuals aged 6 months or older in the republic of korea, using a self-controlled case series (sccs) design secondary objective: - to describe the frequency and estimate the incidence ratio of severe covid-19 outcomes (covid-19 hospital admission, covid-19 intensive care unit \[icu\] admission, and covid-19 death).

Eligibility criteria:
1. primary objectives 1-1. measure of occurrence inclusion criteria for the measure of occurrence, analytical populations will include following individuals, * who meet the predefined criteria for each study population. * with enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period. exclusion criteria for the measure of occurrence, analytical populations will exclude following individuals, * with diagnosis of aesi during the aesi-specific clean window; or * with diagnosis of aesi between first dose and second/third dose of primary series when analyzing for the second/third dose. 1-2. measure of association inclusion criteria for the measure of association, analytical populations will include following individuals, * who meet the predefined criteria for each study population. * with enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and * who had incident aesi during the observation period. exclusion criteria for the measure of association, analytical populations will exclude following individuals, * who do not have both risk and control window time. if an individual disenrolls, dies, or reaches the end of the study period during the risk window prior to accumulating any control window time, he/she will be excluded; or * with a diagnosis of aesi during the aesi-specific clean window. 2. secondary objective inclusion criteria for the secondary objective, the study populations will include following individuals, * who meet the predefined criteria for each study population. exclusion criteria * none

Keywords: covid-19 vaccines safety sars-cov-2
in2shape: a study of physical activity and depressive symptoms in adolescence

Conditions: Depression

Summary: the purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents.

the primary objective of the project is to establish whether increasing physical activity can promote mental well-being in adolescents who are already displaying some depressive symptoms. a further objective is to evaluate the feasibility of a novel self-motivated physical activity intervention, which has been designed for this project. the final objective of this project is to investigate alternative intervention delivery modes, for an adolescent sample with subclinical depressive symptomatology, i.e., presenting with some depression symptoms but not at a level where major depressive disorder would be diagnosed. we aim to compare the effect of a completely mediated delivery approach for physical activity (i.e., no researcher contact) and a mediated intervention with face-to-face contact and fortnightly check-in telephone calls.

Eligibility criteria:
inclusion criteria: * adolescents from grades 7-10 (high school) and their parents/guardians. * adolescents scoring in the middle range (14-30) on the centre for epidemiological studies-depression scale (possible range 0-60). exclusion criteria: * adolescents currently engaging in 60+ minutes of physical activity per day. * adolescents who have experienced psychosis, schizophrenia or bipolar disorder. * adolescents who score \>30 on the ces-d (indicator of severe depression). * adolescents who have physical health problems or conditions which preclude them from participation in regular physical activity. * lack of written consent from adolescent and/or parent guardian.

Keywords: depression motor activity adolescent
comparison between sit-to-stand test and six-minute walk test in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients


Eligibility criteria:
inclusion criteria: * clinically stable for a minimum of 4 weeks * no recent infectious exacerbations exclusion criteria: * musculoskeletal or joint disorders * contra-indications to perform exercises
health-related quality of life and patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol

Conditions: Rheumatoid Arthritis

Summary: the main objective is to assess health-related quality of life (hrqol) according to physical function, as measured by a specific questionnaire (health assessment questionnaire), in rheumatoid arthritis (ra) patients who begin therapy with subcutaneous anti-tumour necrosis factor alpha (tnfα) certolizumab pegol (czp).

an open-label, prospective, and post-authorization observational study. this non-interventional study is designed to establish the importance of the measurement of hrqol data and patient-reported outcomes in clinical practice in patients with ra, and to assess efficacy and safety use of czp according to the summary of product characteristics.

Eligibility criteria:
inclusion criteria: * patient is male or female, aged 18 years or older * patient has active rheumatoid arthritis according to american college of rheumatology (acr) criteria with duration ≥ 3 months * patient has das28 (esr) \> 4.5 and crp \> 1.0 mg/dl at baseline * patient has failed previous disease modifying anti-rheumatic drugs (dmards) including methotrexate treatment * patient has initiated treatment with subcutaneous anti-tumour necrosis factor alpha (anti-tnfα) czp, administered every 2 weeks * patient has no other prior anti-tnfα treatment (naïve patient) or czp is administered after failure to the first anti-tnfα treatment (first switch patient) * patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician * patient has signed and dated a written informed consent form * the patient's treatment must be within the terms of summary of product characteristics (smpc) exclusion criteria: * patient has a known hypersensitivity to the active substance or to any of the excipients * patient has active tuberculosis or other severe infections such as sepsis or opportunistic infections * patient has moderate to severe heart failure (new york heart association (nhya) classes iii/iv) * patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires * pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy

Keywords: cimzia non-interventional multicenter postmarketing local
chronic kidney disease progression in chronic hepatitis b patients on tenofovir alafenamide (taf) versus entecavir

Conditions: Chronic Hepatitis B

Summary: tenofovir alafenamide (taf), a novel prodrug of tenofovir (tfv), has been approved for the treatment of chronic hepatitis b virus (hbv) infection. taf has been shown to be a potent inhibitor of hbv replication at a low dose, with high intracellular concentration and more than 90% lower systemic tfv concentration than tenofovir disoproxil fumarate (tdf). taf has been approved in the clinical practice guidelines in the west. since its availability in asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials. the primary objective of this study is to compare the risk of chronic kidney disease (ckd) progression in chronic hepatitis b patients on taf versus etv in a territory-wide cohort in hong kong.

antiviral therapy with nucleos(t)ide analogues (nas) has revolutionized the management of chronic hepatitis b (chb) in the last two decades.1 entecavir (etv), a nucleoside analogue, is one of the first-line nas recommended by all international treatment guidelines.2-4 as hepatitis b surface antigen (hbsag) seroclearance rarely occurs, most patients require long-term, if not life-long, na therapy. hence, the safety of nas requires careful scrutiny. in clinical trials, nephrotoxicity may occur in a small proportion of patients receiving nucleotide analogues. we previously demonstrated that tenofovir disoproxil fumarate (tdf) was associated with mild renal impairment in a minority of patients; those treated with entecavir (etv) had a similar risk compared to untreated patients.5 tenofovir alafenamide (taf), a novel prodrug of tenofovir (tfv), has been approved for the treatment of chronic hepatitis b virus (hbv) infection. taf has been shown to be a potent inhibitor of hbv replication at a low dose, with high intracellular concentration and more than 90% lower systemic tfv concentration than tenofovir disoproxil fumarate (tdf). taf has been approved in the clinical practice guidelines in the west. since its availability in asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

Eligibility criteria:
inclusion criteria: * positive hepatitis b surface antigen (hbsag) or documented history of chb for 6 months or more; and * on taf 25 mg daily as antiviral treatment for chb (cases); or * on etv 0.5 to 1.0 mg daily as antiviral treatment for chb (controls) exclusion criteria: * previous na treatment prior to taf or etv * positive antibody against hepatitis c, d, or human immunodeficiency virus (anti-hcv, anti-hdv, or anti-hiv) * evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease). * moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers * non-hepatic cancer undergoing chemotherapy within last 6 months
early detection of cardiac affection in patients of wilson's disease

Conditions: Cardiovascular Diseases; Wilson's Disease

Summary: wilson disease (wd) is a rare autosomal recessive disorder caused by a genetic defect in atp7b resulting in limited excretion of excess copper into the bile pathological copper accumulation occurs in the entire body, with the liver and the brain being primarily affected

wilson disease (wd) is a rare autosomal recessive disorder caused by a genetic defect in atp7b resulting in limited excretion of excess copper into the bile. pathological copper accumulation occurs in the entire body, with the liver and the brain being primarily affected. the pathological copper accumulation may induce toxic injury, including mitochondrial dysfunction or apoptosis . exhausted hepatic copper storage capacity causes copper release into the bloodstream thus affecting other organs, in particular the brain. the neurotoxicity of copper primarily damages astrocytes, leading to a regional destruction of the blood-brain barrier with subsequent neurological symptoms. asymptomatic cardiac arrhythmias are quite common in wd. cardiomyopathy, autonomic dysfunction, and cardiac deaths due to copper accumulation in cardiac tissue have occasionally been reported in wd. copper accumulation induces toxic effects in cardiomyocytes and the clinical consequences of these myocardial accumulations are poorly understood. previous studies have mainly reported mild cardiac abnormalities including concentric hypertrophy, impaired left ventricular (lv) relaxation and minor electrocardiographic changes, mainly reported in the times before appropriate treatment was available. a longitudinal cohort study demonstrated a higher incidence of heart failure (hf) and atrial fibrillation in wd patients, indicating a potential adverse effect of copper on the heart. cardiovascular magnetic resonance (cmr) allows for a non-invasive tissue characterization, specifically visualizing edema, fibrosis, and pathological infiltrations. cmr has been successfully used for diagnosis and therapy monitoring in other storage diseases such as myocardial iron overload and amyloidosis. survival in patients with thalassemia major improved significantly after the introduction of cmr for identifying myocardial iron accumulation. imaging regional fibrosis using cmr late gadolinium enhancement (lge) and quantitative measurement of extracellular volume (ecv) provide independent prognostic markers in cardiac amyloidosis.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with wilson's exclusion criteria: * claustrophobia * refusal to share information * heart failure

Keywords: wilson's cmr cardiac magnetic resonance
intraventricular stasis in cardiovascular disease

Conditions: Dilated Cardiomyopathy; Thrombosis Cardiac; Stroke; Hypertrophic Cardiomyopathy

Summary: this study is designed to quantify the ventricular stasis in patients with different forms of cardiomyopathy and at risk of stroke (ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy) by post-processing of 2d color doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis.

cardioembolic stroke is a major source of mortality and disability worldwide and blood stasis inside the heart is the main risk factor for developing intracardiac thrombosis. we have recently developed and patented a quantitative image-based method to map blood stasis within the cardiac chambers. the method is suitable for any medical imaging modality that provides time-resolved flow maps inside the heart (magnetic resonance, echocardiography, or computational-fluid-dynamic processing from anatomical ct images). the objective of the present project is to validate this certified technology in a multicentric cross-sectional clinical trial of 258 patients with different forms of cardiomyopathy with high-risk of stroke. we will include patients with ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy in sinus rhythm and an echocardiogram, cardiac and cerebral mri will be performed. our objective is to quantify the ventricular stasis by post-processing of 2d color doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent brain infarctions (sbis) and intracavitary thrombosis determined by magnetic resonance (mri).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * sinus rhythm. * meet one of the following criteria: * diagnosis of non ischemic dcm and ejection fraction (ef) of lv less than 45% * diagnosis of ischemic dcm and ejection fraction (ef) of lv less than 45% * diagnosis of hypertrofic myocardiophathy and ejection fraction (ef) of lv less than 55% or apical aneurism diagnosed in an image test. exclusion criteria: * implantable defibrillation or stimulation devices not compatible with mri. * hemodinamically significant heart valve disease or prosthetic heart valves. * claustrophobia. * persistent of paroxysmal atrial fibrillation (af). * prior history of significant carotid disease with stenosis greater than 50%. * full anticoagulation therapy prior to admission or indication of anticoagulation. * pro-thrombotic disorders (active oncology disease, coagulation disorders...)

Keywords: dilated cardiomyopathy hypertrophic cardiomyopathy cardiac thrombosis silent brain infarct stroke fluid dynamics intracardiac blood flow echocardiography phase contrast magnetic resonance imaging
silybin - vitamin e- phospholipids complex reduces liver fibrosis in patients with chronic hepatitis c treated with peg-ifn-a and rbv

Conditions: Liver Fibrosis

Summary: chronic hepatitis c is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and hcc. the investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin e-phospholipids in patients with chronic hepatitis c treated with pegylated-interferon-α2b plus ribavirin.


Eligibility criteria:
inclusion criteria: * 18 years of age or older, * infection by hcv * under treatment with pegylated interferon 2 alpha and ribavirin exclusion criteria: * other liver diseases * cancer * severe jaundice * pulmonary and renal chronic diseases * prostatic diseases * autoimmune diseases * diabetes mellitus